Trump administration's coronavirus efforts in Indian Country plagued by lack of accurate data

Thursday, May 14, 2020

By Acee Agoyo

The Trump administration's coronavirus testing efforts in Indian Country are being dealt a serious setback with warnings about the accuracy of the machine provided to tribal communities across the nation.

During a media call on Thursday afternoon, the Indian Health Service touted the 250 Abbott machines that are being used to return rapid COVID-19 results, some as quickly as within five minutes. One official described it as a "White House effort" that has provided more than 90,000 testing supplies to tribal communities, some of which have been hit hard during the pandemic.

"IHS continues to focus on getting supplies to hot spots," Chief Medical Officer Michael Toedt said on the call.

Just a few hours later, another federal agency raised significant doubts about the Abbott machines, one of which was delivered last week by President Donald Trump himself to a leader from the Navajo Nation, a coronavirus hot spot. Citing emerging data, the Food and Drug Administration said the test "may return false negative results," meaning it does not always detect when a person has contracted COVID-19.

“We are still evaluating the information about inaccurate results and are in direct communications with Abbott about this important issue," said Tim Stenzel, a director within the FDA’s Center for Devices and Radiological Health, which like the IHS, is part of the larger Department of Health and Human Services.

Indianz.Com Audio: Indian Health Service Media Call - May 14, 2020

Tribal leaders began raising concerns about the accuracy of the Abbott tests last month, when the IHS began distributing the machines after the Trump administration faced criticism for moving too slowly to respond to the crisis. During weekly calls organized by the White House, they pointed to early studies which they said could raise false hopes in Indian Country.

One tribal leader said the Abbott test returned 25 percent false negatives in the community, according to participants. Another had read reports warning of inaccurate results and voiced concerns during a call in April.

Despite the doubts, Trump administration officials did not respond to the inquiries in substantive ways, participants said. But the false negatives haven't been the only complaint to emerge about the Abbott machines.

The Navajo Nation waited weeks for the machines to arrive in mid-April, President Jonathan Nez said. When they finally showed up, he said tribal and IHS facilities on the largest reservation in the U.S. had to waste precious supplies just to get them working properly.

Navajo Nation: Town Hall - April 21, 2020

"It takes many of these tests just to calibrate one," Nez said during a town hall on April 21.

Additionally, he said the Abbot machine relies on proprietary testing supplies that can only be obtained from the company. At the time, the kits were on back order.

"If we get through all these test kits, we're going to be out, we're going to be waiting again," Nez said.

"We'll see how long that will last," Nez added.

Other providers have run into similar issues with the Abbot machines. The Oyate Health Center, a tribally-managed facility in Rapid City, the second most populous area in South Dakota, has only been given access to 24 test kits per week, Chief Executive Officer Jerilyn Church said on a Congressional town hall on April 17.

House Committee on Natural Resources: Coronavirus Response in Indian Country

The lack of adequate supplies has real consequences. The Oyate Health Center tested 46 people last week alone, exhausting a significant portion of its allocation.

"It is widely known that American Indians and Alaska Natives are at higher risk for serious illness or death if infected with the COVID-19 virus," Church, who also serves as CEO of the Great Plains Tribal Chairmen’s Health Board, the entity that oversees the Oyate Health Center, said on Monday. Of the 46 tests, 12 returned positive, Church said.

Great Plains Tribal Chairmen’s Health Board: Oyate Health Center Update - May 11, 2020

Abbott Laboratories is a publicly traded company based in Illinois. The firm was granted an Emergency Use Authorization (EUA) from the FDA for the "ID NOW" COVID-19 test on March 27.

On Wednesday, the company disputed the results of a widely-publicized New York University study which raises doubts about the accuracy of the ID NOW test. A short statement said it was "not consistent with other studies" which showed high rates of accuracy.

A longer update was provided on Thursday. The company said the machine was being used improperly by some researchers.

"We're seeing studies being conducted to understand the role of ID NOW in ways that it was not designed to be used," the company said.

"While we understand no test is perfect, test outcomes depend on a number of factors including patient selection, specimen type, collection, handling, storage, transport and conformity to the way the test was designed to be run," the statement continued. "ID NOW is intended to be used near the patient with a direct swab test method."

According to the FDA's release on Thursday, the agency has received "15 adverse event reports about the Abbott ID NOW device that suggest some users are receiving inaccurate negative results." The data still must be verified but the warning was sent out "in the spirit of transparency."

I wonder if the Indian Health Service knows Abbott tests miss almost half of all positive infections, according to a study at New York University. This is a big problem Indian country doesn’t need. https://t.co/sI1wu3hDgj https://t.co/s92MLHvwei
— Ruth Hopkins ⚡️❤️⚡️ (@Ruth_HHopkins) May 14, 2020

As of May 13, 68,717 coronavirus tests have been conducted within the IHS system. Of those, 6,436 have returned positive for COVID-19, according to the results. That represents an increase of nearly 7.3 percent from the 5,999 cases previously reported.

"We are testing very heavily," noted Loretta Christensen, the Chief Medical Officer for the Navajo Area of the IHS, the region that has seen the most COVID-19 cases in Indian Country..

Overall, testing increased by 9.9 percent between May 12 and May 13, the data shows. It grew by 5 percent between May 11 and May 12.

In the spirit of transparency, FDA is alerting the public to early data suggesting potential inaccurate results during the Abbott ID NOW point of care #COVID19 test, specifically false negative results. https://t.co/rayPkde8oy pic.twitter.com/15Rh4Y50YN
— U.S. FDA (@US_FDA) May 15, 2020

The data, however, is incomplete, the IHS notes on its website. While 100 percent of facilities directly run by the agency are reporting coronavirus testing results, the same cannot be said for other providers within the system.

Only about 33 percent of tribally managed facilities and 44 percent of urban Indian organizations are disclosing testing data, the IHS told Indianz.Com after the media call on Thursday.

"All of the tribes and urban Indian organizations are continuing to increase their reporting, and as this pandemic goes on, there's been certainly a strong willingness in participation from all of those entities," Toedt said on the call.